BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 2024197 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00798
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE INSULATION WAS PEELED 1.5CM TO 7CM FROM THE DISTAL TIP. THE METAL CANNULA IS EXPOSED IN THE AREA OF INSULATION DAMAGE AND A SLIGHT BEND WAS OBSERVED AT THE DISTAL END OF THE CANNULA. ADDITIONALLY, MARKINGS WERE PRESENT ON THE DEVICE PLUNGER WHICH IS INDICATIVE OF USE IN A PARTIAL DEPLOYMENT SCENARIO. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE EXTENDED AND RETRACTED WITHOUT ISSUE. CONTINUITY OF CURRENT WAS CONFIRMED BETWEEN THE ELECTRODE AND THE AREA OF INSULATION DAMAGE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT OF INSUFFICIENT ROLL-OFF. THE EVALUATION CONFIRMED THAT THE ELECTRODE INSULATION WAS DAMAGED. THEREFORE, ANY ENERGY DELIVERED FROM THE GENERATOR WOULD LIKELY HAVE BEEN DEPLETED AT THE EXPOSED METAL IN THE AREA OF INSULATION DAMAGE. HOWEVER, SINCE AN EXACT CAUSE OF THE INSULATION DAMAGE OR INSUFFICIENT ROLL-OFF COULD NOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE OF UNDETERMINABLE HAS BEEN ASSIGNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00881 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF (B)(4) RADIOFREQUENCY GENERATOR AND A LEVEEN NEEDLE ELECTRODE WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMPEDANCE BECAME UNSTABLE AFTER THE FIFTH ABLATION TREATMENT. THE LEVEEN NEEDLE ELECTRODE WAS WITHDRAWN FROM THE PATIENT AND THE INSULATION WAS FOUND TO HAVE PEELED. IT IS NOT KNOWN IF THE INSULATION PEELED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S ELECTRODE (COOL TIP) AND GENERATOR. A RF (B)(4) RADIOFREQUENCY GENERATOR COMPLAINT (MANUFACTURER REPORT # 3005099803-2011-00881) WAS OPENED BASED ON INFORMATION RECEIVED BY THE ACCOUNT ON (B)(6) 2011 WHICH INDICATED THAT ROLL-OFF HAD NOT BEEN ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00881 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN NEEDLE ELECTRODE WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMPEDANCE BECAME UNSTABLE AFTER THE FIFTH ABLATION TREATMENT. THE LEVEEN NEEDLE ELECTRODE WAS WITHDRAWN FROM THE PATIENT AND THE INSULATION WAS FOUND TO HAVE PEELED. IT IS NOT KNOWN IF THE INSULATION PEELED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S ELECTRODE (COOL TIP) AND GENERATOR. A RF 3000 RADIOFREQUENCY GENERATOR COMPLAINT (MANUFACTURER REPORT # 3005099803-2011-00881) WAS OPENED BASED ON INFORMATION RECEIVED BY THE ACCOUNT ON (B)(6), 2011 WHICH INDICATED THAT ROLL-OFF HAD NOT BEEN ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262290 13278019

    Patients

    Seq Age Sex Outcome Treatment
    1